Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications, including: AM, Arch Biopartners, Aslan, Atyr, Basilea, Cerecor, Codagenix, Creative Medical Technology, Dalcor, Dr. Reddy’s, Edesa, Immutep, Kintor, Mesoblast, Neurorx, Quantum Leap Healthcare, Relief, Russian Direct Investment Fund, Sanbio, Serum Institute of India, Windtree.
Biopharmas in Asia-Pacific raising money in public or private financings, including: Ascendis, Gracell, Ligature, Paratek, Revelation Biosciences, Visen, Zai Lab.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CMS finalizes MCIT rule; HHS lists permanent waivers of notification; FDA schedules advisory meeting for latest Lutonix model; HHS announces telehealth grants; Telemarketer caught in sting over telehealth fraud; Churn at FDA chief counsel’s office.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biomerica, Cognito Therapeutics, Cytosorbents, Jud Care, Medskin Solutions Dr. Suwelack, Microvention, Ortho, Quanterix, Therapixel.